Pharm-Olam is a mid-sized, global CRO that provides clinical research solutions with a specialization in allergy and autoimmune diseases. Our organization was hired to support a Phase I study for a subcutaneous immunotherapy in adult and pediatric subjects with peanut allergy. Pharm-Olam is proud to have supported this critical research, the patients, and the sponsor involved.
Pharm-Olam managed three age groups over seven sites – adults (18-50), adolescents (12-17), and pediatrics (5-11). Six of the sites were located in the United States – evenly divided between university-based and small clinic-based locations. There was an additional site in Canada, which was a dedicated clinical research center.
Enrollment for the study was challenging because of the nature of the study, the severity of the allergies tested, and issues surrounding consent and general participation demands for the underage patients. Peanut allergies are often very severe and they may present with comorbidities such as asthma. In many cases, the presence of these issues would have precluded a patient from participation. Furthermore, the patient could not have an autoimmune condition or any issue that would interfere with the observation of the subcutaneous immunotherapy drug being tested.
We also encountered issues relating to managing dosing within age groups. The study was structured in such a way that patients would be evaluated at each dosing whether the amount of the drug they received should increase, decrease, or remain the same and the impact of that dosing had to be considered based on patient age, weight, and development.
Finally, the issue of securing informed consent became paramount within the early age groups. Different states have different requirements as to how a researcher should obtain consent for an underage patient. In some locations, the standard is one parent while in others, the consent of both parents is required. Ultimately, the sponsor opted to default to the strictest requirement. This limited the available patient population but it streamlined our management of the consent process / expectation set for all parties involved.
Pharm-Olam was able to deliver a fully enrolled study because of our deep expertise in the field of allergies. We are grateful to our patients, our sites, and our sponsor for the opportunity to support research into the use of subcutaneous immunotherapy in adult and pediatric subjects with peanut allergy.